What are the best pharmacologic treatments for intestinal pseudo-obstructions?

Comment by InpharmD Researcher

Neostigmine remains the only pharmacologic agent with consistent controlled evidence and guideline endorsement for acute colonic pseudo-obstruction, with multiple trials and meta-analyses demonstrating high response rates when used after failure of conservative therapy. In contrast, pharmacologic management of adult chronic intestinal pseudo-obstruction and pediatric PIPO is based on very low–quality evidence and is largely adjunctive and individualized, with agents such as pyridostigmine, prucalopride, and other prokinetics supported mainly by small series, observational data, and expert consensus.

Background

Acute colonic pseudo-obstruction (ACPO):
The 2020 American Society for Gastrointestinal Endoscopy (ASGE) guideline identifies neostigmine as the pharmacologic agent of choice for ACPO and recommends its use in patients who are not candidates for conservative therapy, who have failed conservative therapy for up to 72 hours, or who are at risk for perforation and have no contraindication to treatment. During administration, continuous cardiac and respiratory monitoring is required, with immediate access to atropine for bradycardia, and glycopyrrolate may be coadministered to reduce hypersalivation and bronchospasm. Contraindications include intestinal or urinary obstruction and hypersensitivity, and relative contraindications include bradycardia, asthma, renal insufficiency, peptic ulcer disease, recent myocardial infarction, and acidosis. A standard dose of 2 mg IV over 3 to 5 minutes is recommended, and in patients who fail an initial dose, are partial responders, or experience recurrence, a second dose has been associated with clinical responses in 40% to 100% of cases. The guideline notes that alternative neostigmine regimens, including subcutaneous administration and continuous intravenous (IV) infusion at 0.4 to 0.8 mg/hour over 24 hours, have been reported to be effective, sometimes with fewer adverse effects. For cases refractory to neostigmine, additional pharmacologic agents described in the guideline include oral pyridostigmine, methylnaltrexone, and traditional prokinetics such as metoclopramide and erythromycin, as well as prucalopride in a reported case of acute refractory pseudo-obstruction, though further evidence is needed before these therapies can be routinely recommended. [1]

Guidelines published by the American Society of Colon and Rectal Surgeons (ASCRS) in 2021 recommend treatment with neostigmine when acute colonic pseudo-obstruction (ACPO) does not resolve with supportive therapy, which is issued as a strong recommendation based on moderate-quality evidence. Neostigmine is generally administered as an IV bolus dose of 2 to 2.5 mg, consistent with the 2 mg IV dose used in the landmark randomized trial by Ponec et al. A prominent meta-analysis reported that a single IV dose of 2 to 5 mg achieved clinical success in 60–94% of patients, with recurrence rates ranging from 0–31% and overall long-term response rates of 69–100%. Studies have also described comparable efficacy and safety with continuous IV infusion, particularly in patients who are refractory to bolus dosing, although continuous infusion may be associated with increased bradycardic events. Tables 1–4 of the guideline summarize the major clinical trials supporting these recommendations. [2]

A review of literature on the safety and effectiveness of neostigmine for the treatment of postoperative ACPO suggests neostigmine as an effective treatment option if patients have failed conservative treatment measures. Data, primarily from observational studies, have found that neostigmine reduced the duration of ACPO compared to conservative treatment alone, improved clinical symptoms, and led to fewer recurrent episodes for patients who failed conservative management. However, its role as first-line therapy for ACPO remained equivocal. Besides commonly described anticholinergic effects from neostigmine, patients should be under close cardiac monitoring for prompt identification of bradycardia, which has been reported to be managed with atropine. The authors have highlighted notable limitations, including the heterogeneity in study populations, use of adjuvant agents, neostigmine regimens, and variety in methodology and measurement of outcomes. A summary of the examined studies can be found in Table 1. [3], [4]

A 2014 meta-analysis included four studies (N= 127 patients) to assess the effectiveness and safety profile of neostigmine in the treatment of patients with ACPO. Only three studies used IV neostigmine (dose range, 2-5 mg) with an administration time ranging from 3 minutes to 12 hours. Acute colonic pseudo-obstruction was resolved in 89.2% ​​(ranging from 84.6 to 95.2%) in the neostigmine group compared to 14.8% (from 0.0 to 45.0%) in the placebo group (NNT= 1; 95% confidence interval [CI], 1 to 2). Abdominal pain (53.1%; odds ratio [OR] 17.4, 95% CI, 5.3 to 57.2) followed by sialorrhoea (31.1%; OR 9.4, 95% CI 3.0 to 29.2) were the most common adverse events reported in the studies. Other less common side effects included vomiting (15.6%) and bradycardia (6.3%). The authors noted that, given the considerable heterogeneity and relatively low power of studies, the role of neostigmine as first-line therapy for ACPO and its optimum dose remains unclear. [5]

Chronic intestinal pseudo-obstruction (CIPO) – adults:
The 2020 British Society of Gastroenterology (BSG) guideline on adult chronic intestinal dysmotility notes that pharmacologic therapy offers limited and variable benefit and should be directed by symptom profile. The guideline emphasizes first eliminating medications that impair motility, especially opioids, anticholinergics, and chronic cyclizine, because these can mimic or worsen pseudo-obstruction. Prokinetic agents may be used on a trial basis, including prucalopride, erythromycin, metoclopramide, and octreotide, though evidence supporting any agent is weak and responses are inconsistent. Octreotide may improve migrating motor complexes in neuropathic dysmotility, while erythromycin predominantly benefits gastric emptying. Additional pharmacologic measures include targeted antibiotics for small intestinal bacterial overgrowth and cautious use of neuropathic pain agents to avoid further slowing motility. Overall, the guideline characterizes drug therapy as adjunctive and modest in effect, best utilized within a multidisciplinary management strategy. [6]

The 2020 review emphasizes that pharmacologic therapy in CIPO is limited by a lack of high-quality evidence, and most available agents provide only partial or symptomatic benefit. The review notes that prokinetic agents such as metoclopramide, domperidone, and erythromycin have been used to stimulate upper gastrointestinal motility, although their efficacy in CIPO is generally modest and often transient. Octreotide is described as beneficial in select neuropathic cases due to its ability to induce migrating motor complexes, whereas anticholinesterase agents such as neostigmine and pyridostigmine may improve intestinal propulsion in some patients, particularly those with neuropathic dysmotility. The review underscores that no pharmacologic therapy has demonstrated consistent, robust improvement across the CIPO population, and that treatment remains largely individualized, with drugs used as adjuncts to nutritional support, decompression strategies, and management of complications such as small intestinal bacterial overgrowth. Overall, the pharmacologic landscape is characterized as limited, variably effective, and supported primarily by small studies and case series. [7]

Pediatric intestinal pseudo-obstruction (PIPO):
The 2018 ESPGHAN/NASPGHAN guideline on PIPO establishes standardized diagnostic criteria and structured management but emphasizes that pharmacologic therapy has virtually no evidence base, with recommendations derived almost entirely from expert consensus and very low-quality evidence (e.g., GRADE D). The guideline distinguishes PIPO from adult CIPO and stresses early referral to expert centers, multidisciplinary evaluation, and optimization of nutrition as the foundation of therapy. For medications, the working group notes that available data consist mainly of anecdotal experience and extrapolation from adult literature, and therefore issues only weak suggestions regarding the selective use of prokinetic agents (for example, to guide therapy when antroduodenal manometry predicts responsiveness) and the cautious use of antibiotics for small-bowel bacterial overgrowth. Drug treatment is framed as adjunctive, with no strong or evidence-based pharmacologic recommendations, and clinical decisions should rely on physiologic testing, symptom profile, and multidisciplinary oversight. [8]

A 2023 survey conducted among the Intestinal Failure (IF) teams within the European Reference Network for rare Inherited and Congenital Anomalies (ERNICA) investigated current diagnostic and management strategies for PIPO. The survey included 11 ERNICA IF centers from 8 countries, each with distinct approaches to managing this rare condition. From April 2020 to June 2022, the survey, comprising 49 closed questions, captured detailed insights into the diagnostic protocols and management practices for PIPO across these centers. The participating centers reported a total of 102 PIPO patients under follow-up, with 78% of these patients dependent on parenteral nutrition (PN). The survey highlighted diverse strategies in the nutritional, medical, and surgical management of PIPO. Nutritional care predominantly prioritized oral feeding, with multidisciplinary teams guiding individualized enteral and PN management. Medical management varied widely, with no prokinetic medications uniformly prescribed across all centers. Surgical strategies included decompressing ileostomy and venting gastrostomy, but the approach to small bowel resection was inconsistent. The findings indicate that while the diagnostic protocols for PIPO generally adhere to international guidelines, considerable variation exists in the management strategies employed by ERNICA IF teams. [9]

The 2022 systematic review provides an updated synthesis of PIPO. In terms of management, the review supports a multidisciplinary approach centered on optimized nutrition and careful use of pharmacologic therapy. Consistent with the ESPGHAN guideline evidence base, it notes that no pharmacologic agent has proven reliably effective, but summarizes emerging pediatric data showing potential benefit from prucalopride, pyridostigmine, and other prokinetics, largely from small case series. It also identifies adjunctive therapies under investigation, including cannabinoids, herbal medicines, fecal microbiota transplantation, and immunotherapy for autoimmune GI dysmotility, while stressing that these remain experimental and require further validation. Intestinal transplantation continues to serve as a life-saving intervention for severe, PN-dependent disease. Overall, the review emphasizes major gaps in evidence and the need for continued research but affirms current consensus-based strategies for diagnosis and management. [10]

References:

[1] Naveed M, Jamil LH, Fujii-Lau LL, et al. American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the management of acute colonic pseudo-obstruction and colonic volvulus [published correction appears in Gastrointest Endosc. 2020 Mar;91(3):721]. Gastrointest Endosc. 2020;91(2):228-235. doi:10.1016/j.gie.2019.09.007
[2] Alavi K, Poylin V, Davids JS, et al. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Colonic Volvulus and Acute Colonic Pseudo-Obstruction. Dis Colon Rectum. 2021;64(9):1046-1057. doi:10.1097/DCR.0000000000002159
[3] Elsner JL, Smith JM, Ensor CR. Intravenous neostigmine for postoperative acute colonic pseudo-obstruction. Ann Pharmacother. 2012;46(3):430-435. doi:10.1345/aph.1Q515
[4] Kayani B, Spalding DR, Jiao LR, Habib NA, Zacharakis E. Does neostigmine improve time to resolution of symptoms in acute colonic pseudo-obstruction?. Int J Surg. 2012;10(9):453-457. doi:10.1016/j.ijsu.2012.08.008
[5] Valle RG, Godoy FL. Neostigmine for acute colonic pseudo-obstruction: A meta-analysis. Ann Med Surg (Lond). 2014;3(3):60-64. Published 2014 Jun 19. doi:10.1016/j.amsu.2014.04.002
[6] Nightingale JMD, Paine P, McLaughlin J, et al. The management of adult patients with severe chronic small intestinal dysmotility. Gut. 2020;69(12):2074-2092. doi:10.1136/gutjnl-2020-321631
[7] Zhu CZ, Zhao HW, Lin HW, Wang F, Li YX. Latest developments in chronic intestinal pseudo-obstruction. World J Clin Cases. 2020;8(23):5852-5865. doi:10.12998/wjcc.v8.i23.5852
[8] Thapar N, Saliakellis E, Benninga MA, et al. Paediatric Intestinal Pseudo-obstruction: Evidence and Consensus-based Recommendations From an ESPGHAN-Led Expert Group. J Pediatr Gastroenterol Nutr. 2018;66(6):991-1019. doi:10.1097/MPG.0000000000001982
[9] Mutanen A, Demirok A, Wessel L, Tabbers M; ERNICA IF Working Group. Pediatric Intestinal Pseudo-Obstruction: An International Survey on Diagnostic and Management Strategies in the European Reference Network for Rare Inherited and Congenital Anomalies Intestinal Failure Teams. J Pediatr Gastroenterol Nutr. 2023;77(1):24-30. doi:10.1097/MPG.0000000000003788
[10] Turcotte MC, Faure C. Pediatric Intestinal Pseudo-Obstruction: Progress and Challenges. Front Pediatr. 2022;10:837462. Published 2022 Apr 13. doi:10.3389/fped.2022.837462

Literature Review

A search of the published medical literature revealed 4 studies investigating the researchable question:

What are the best pharmacologic treatments for intestinal pseudo-obstructions?

Level of evidence

B - One high-quality study or multiple studies with limitations  Read more→



Please see Tables 1-4 for your response.


Summary of neostigmine studies 
Reference  Design (patients, N) Dose, mg Response rate Response timea Adverse effects (n)
Stephenson, 1995  Prospective observational (N= 12) 2.5 12 (100%) 3-20 minutes (range)

Sweating (3), transient bradycardia (1)

Turégano-Fuentes, 1997 Prospective observational (N= 16d) 2.5 13 (81) 20 minutes-4 hours (range) Bradycardia (n= 1)
Ponec, 1999 RCT (N= 21) 2

Neostigmine: 10/11 (91%)

Placebo: 0/10 (0)

4 minutes Abdominal pain (n= 13), symptomatic bradycardia (n= 2)b
Trevisani, 2000 Prospective observational (N= 28) 2.5 26 (93) 30 seconds-10 minutes (range)

Abdominal cramps, nausea, light-headedness, sweating

Althausen, 2000 Prospective observational (N= 7) 2 6 (85%) 5.25 minutes

Abdominal pain (n= 5), transient bronchospasm (n= 1)

Paran, 2000 Prospective observational (N= 11) 2.5 9 (81%) 90 minutes (mean)

None reported

Abeyta, 2001 Retrospective observational (N= 10) 2 9 (90%) 22.8 minutes (mean)

Bradycardia (n= 1)b

van der Spoel JI, 2001

Double-blinded, placebo-controlled prospective study (N= 24)

0.4-0.8 mg/hour over 24 hours (continuous intravenous infusion) 

Neostigmine: 11/13 (95%; p< 0.001)  

Placebo: 0/11 (0) 

6 hours (IQR 4-9 hours) Ischemic colonic compoolications (n= 3) 
Loftus, 2002  Retrospective observational (N= 18c) 11 (61%) <30 minutes Bradycardia (n= 2)b
Mehta, 2006  Prospective observational (N= 19)

IR 16 (84%)

SR 15 (79%)

14 hours Bradycardia (n= 2)

IQR = interquatile range; IR = initial response; P = placebo; RCT = randomized controlled trial; SR = sustained response.
aReported as median unless otherwise noted.
bTreated with atropine 1 mg.
cA total of 151 patients were included but only 18 received neostigmine.
dEighteen patients were included but only 16 received neostigmine.

References:

Adapted from:
[1] Elsner JL, Smith JM, Ensor CR. Intravenous neostigmine for postoperative acute colonic pseudo-obstruction. Ann Pharmacother. 2012;46(3):430-435. doi:10.1345/aph.1Q515
[2] van der Spoel JI, Oudemans-van Straaten HM, Stoutenbeek CP, Bosman RJ, Zandstra DF. Neostigmine resolves critical illness-related colonic ileus in intensive care patients with multiple organ failure--a prospective, double-blind, placebo-controlled trial. Intensive Care Med. 2001;27(5):822-827. doi:10.1007/s001340100926

 

Neostigmine for Treating Acute Colonic Pseudo-Obstruction in Neurocritically Ill Patients

Design

Retrospective study

N= 31

Objective

To investigate the effectiveness and adverse events when using neostigmine to manage acute colonic pseudo-obstruction (ACPO) in neurocritically ill patients

Study Groups

Study participants (N= 31)

Inclusion Criteria

Patients with APCO who were treated using neostigmine in the Neurological intensive care unit (ICU) at two centers (Center 1, Seoul National University Hospital, Seoul, Republic of Korea, n=15; Center 2, University of Texas Houston Health Science Center, Houston, TX, USA, n=16)

Exclusion Criteria

Not specified

Methods

Neostigmine was considered if APCO did not respond to conservative management (e.g., correction of electrolyte imbalances, alteration or discontinuation of offending drugs). Either an intravenous (IV) or a subcutaneous (SC) neostigmine injection was given over 5 minutes according to the protocols at each center. The neostigmine dose of 2 mg was used in Center 1, whereas 0.25, 0.5, 1, or 2 mg was used in Center 2. The dose was chosen at the discretion of neuro-intensivists. Clinical responses were observed for up to 3 hours after administering neostigmine. An additional dose of neostigmine was administered in case no bowel movement or relief of abdominal distension. 

Duration

Between March 2017 and August 2020

Outcome Measures

Primary: clinical response, defined by a bowel movement (BM) following neostigmine injection

Secondary: changes in the abdomen circumference and the colon diameter within 24 hours after the injection, clinical improvement outcomes (success of initiating enteral feeding, endoscopic or surgical decompression during hospitalization), safety outcomes (up to 24 hours after the last dose of neostigmine)

Baseline Characteristics

 

Study participants (N= 31)

Age, years

46.8 ± 19.5

Male

20 (65.4%)

Diagnosis at admission

Stroke (ischemic and hemorrhagic)

Status epilepticus

Anti-N-methyl-d-aspartate-receptor encephalitis

Traumatic brain injury

Traumatic spinal cord injury

Cardiac arrest

Astrocytoma

 

11 (35.5%)

7 (22.6%)

4 (12.9%)

4 (12.9%)

3 (9.7%)

1 (3.2%)

1 (3.2%)

Route

Intravenous (IV)

Subcutaneous (SC)

IV and SC

 

28 (90.3%)

2 (6.5%)

1 (3.2%)

Results

Endpoint

Study participants (N= 31)

Efficacy

Time to BM following initiation of neostigmine, median (IQR), minutes

Change in colon diameter, median (IQR), mm

Bowel movement

Enteral feeding after neostigmine

 

120 (60 to 210)

−17.5 (−12.8 to −26.3)

31 (100.0%)

28 (90.3%) 

Safety

Bradycardia

Bronchospasm

Vomiting

Severe salivation

Severe lacrimation

Severe sweating

4 (12.9%)

1 (3.2%)

0 (0.0%)

1 (3.2%)

1 (3.2%)

0 (0.0%)

1 (3.2%)

Adverse Events

See Results 

Study Author Conclusions

In conclusion, neostigmine may be a safe and effective treatment option for neurocritically ill patients with ACPO who fail to respond to conventional medical management. Monitoring of adverse events should be considered despite their low probability. Future clinical trials and larger studies are needed to validate the use of neostigmine and identify the optimal dose and route of administration in neurocritically ill patients.

InpharmD Researcher Critique

Given that retrospective analysis relies heavily on documentation, under-reporting of mild reactions or incomplete record entries may have affected the quality of data. The nonexperimental design lacks control to compare the effect of neostigmine on ACPO. Nonstandardized neostigmine dose across the two centers is considered a confounding factor. 



References:

Kim TJ, Torres L, Paz A, et al. Neostigmine for Treating Acute Colonic Pseudo-Obstruction in Neurocritically Ill Patients. J Clin Neurol. 2021;17(4):563-569. doi:10.3988/jcn.2021.17.4.563

 

Neostigmine treatment protocols applied in acute colonic pseudo-obstruction disease: A retrospective comparative study

Design

Retrospective comparative study 

N= 43

Objective

To analyze the response of patients to different neostigmine protocols

Study Groups

Bolus dose (n= 20)

Continuous infusion (n= 23) 

Inclusion Criteria

Intensive care patients with acute colonic pseudo-obstruction (ACPO) disease; cecal diameters ≥10 cm on plain abdominal radiographs with dilated colonic segments including rectosigmoideum and progressive abdominal distension without any improvement in the next 24 hours, even after conservative treatments

Exclusion Criteria

Atrioventricular conductance disturbances, sinus bradycardia (heart rates <60 bpm) or nodal rhythms, hypotension (systolic blood pressures <90 mmHg), serum creatinine levels >3 mg/dL, intestinal perforation signs (peritoneal irritation findings upon physical examination or intra-abdominal free air displayed on radiological workup), colon cancer or partial colon resection, gastrointestinal bleeding, active bronchospasm, and pregnancy or lactation 

Methods

Patients' electronic medical records were retrospectively reviewed to analyze the effects of bolus dose (BD) compared to the continuous infusion (CI) on treatment outcomes and associated complications. Patients who failed conservative treatments received BD until March 2016 and then CI until September 2017. A favorable clinical response was defined as ≥10% reduction in abdominal distention, large-volume flatus, or defecation greater than 100 mL; favorable radiological response consisted of ≥20% regression in the cecal diameter on plain abdominal radiography. Time to response is defined as the time between the neostigmine application and a clinical-radiological response. 

Bolus doses were given 2 mg neostigmine in 15 min. In the CI group, 5 mg neostigmine was prepared in 50 mL 0.9% NaCl solution and infused at a rate of 4 mL/h (0.4 mg neostigmine/h). If no response was received in 8 hours, the infusion rate was doubled and continued for 24 hours. All patients in intensive care units were continuously monitored for their body temperature, heart rate, oxygen saturation, and electrocardiogram. Before and after the injections, the blood pressure was measured at least every 30 minutes. Atropine for bradycardia (heart rate <50 bpm) and ephedrine for hypotension (systolic pressure <90 mmHg) were also available.

Duration

Between January 2015 and September 2017

Follow-up: 24 hours 

Outcome Measures

Primary: clinical and radiological response 

Secondary: complications 

Baseline Characteristics

 

Bolus dose (n= 20)

Continous infusion (n= 23) 

 

Age, years

72 (21 to 80) 70 (26 to 80)  

Male 

10 12  

Recent surgery

2 3  

Cecal diameter, cm 

12.6 (11.7 to 13.5) 12.6 (11.6 to 13.6)  

Abdominal circumference, cm

115 (107 to 123) 115 (105 to 125)  

Colon decompression

4 7  

Colon complication

1 1  

Baseline characteristics were not significantly different between the two study groups. 

Results

Endpoint

Bolus dose

Continuous infusion 

p-value 

Response to neostigmine

Sustained response on first dose 

Sustained response on second dose

Overall response rate

 

55%

25%

80%

 

60.9%

8.7%

69.6%

 

0.744

0.322

0.378

Mean time to response, minutes (range)

165 (30 to 510) 510 (90 to 1,620) 0.001

Adverse effect

Sinus bradycardia 

Abdominal pain 

Vomiting 

Hypotension 

Bronchospasm

Saliva and sputum 

 

2

5

2

0

1

3

 

0

3

1

0

0

3

 

0.883

0.645

0.601

1

0.926

1

Adverse Events

Two patients who responded to the second dose of neostigmine therapy developed symptomatic bradycardia and were treated with 0.5 mg atropine.

Three patients experienced vomiting, and an antiemetic medication was provided to them.

Bronchospasm developed only in 1 patient, and the patient was treated with oxygen inhalation, bronchodilators, and steroids.

Increased salivation and sputum production in 6 patients were treated by suction.

Study Author Conclusions

The safety and effectiveness of both neostigmine protocols applied to ACPO patients were similar. Clinical and radiological responses were obtained without serious side effects with CI.

InpharmD Researcher Critique

As the study mainly included patients without recent surgical procedures, results may not apply to postoperative settings. Comparative efficacy of BD versus CI in patients unresponsive to the first dose was not directly assessed. 



References:

Ilban O, Cicekci F, Celik JB, et al. Neostigmine treatment protocols applied in acute colonic pseudo-obstruction disease: A retrospective comparative study. Turk J Gastroenterol 2019;30:228-33.

 

Safety and Efficacy of Intermittent Bolus and Continuous Infusion Neostigmine for Acute Colonic Pseudo-Obstruction

Design

Single-center, retrospective cohort study

N= 75

Objective

To compare the clinical response of intermittent bolus versus continuous infusion neostigmine for acute colonic pseudoobstruction (ACPO)

Study Groups

Bolus (n= 37)

Infusion (n= 38)

Inclusion Criteria

Admitted to an intensive care unit (ICU), 18 years of age or older, and received neostigmine for management of ACPO

Exclusion Criteria

Incarcerated, pregnant, received neostigmine for an indication other than ACPO, or had prior surgical intervention for ACPO

Methods

The standard dose for an intermittent neostigmine bolus was 2 mg given as a slow intravenous (IV) push. The continuous infusion was given at the initial rate of 0.4 mg/h, which may be increased to 0.8 mg/h after at least 8 hours if deemed unresponsive. All patients require continuous cardiac monitoring and atropine available at the bedside in case of symptomatic bradycardia.

Duration

From January 1, 2007, to December 1, 2017

Outcome Measures

Primary: initial clinical response, defined as bowel movement (BM) within 4 hours of a bolus dose or 24 hours of initiation of continuous infusion

Secondary: reduction in bowel diameter, time to BM, second neostigmine course post-treatment, colonic decompression post-treatment, surgical intervention post-treatment, ICU length of stay (LOS), hospital LOS, in-hospital mortality, bradycardia, required atropine

Baseline Characteristics

 

Bolus (n= 37)

Infusion (n= 38)

p-value

Age, years

54.3 ± 16.9 59.5 ± 13.3 0.15

Male

32 (86.5%) 32 (84.2%) 0.78

Ethnicity

Hispanic

White

Black

Pacific Islander

Multiracial

Unknown

 

15 (40.5%)

5 (13.5%)

1 (2.7%)

1 (2.7%)

0 (0%)

15 (40.5%)

 

15 (39.5%)

20 (52.6%)

0 (0%)

0 (0%) 

1 (2.6%)

2 (5.3%)

0.0005

 

 

 

 

 

Weight, kg

93.1 ± 25.1 96.1 ± 23.2 0.58

Height, cm

174.0 ± 8.2 174.5 ± 10.0 0.79 

ICU Unit

Surgical/trauma 

Medical 

Neuroscience 

Cardiac/Transplant 

 

13 (35.1%)

10 (27%)

9 (24.3%)

5 (13.5%)

 

21 (55.3%)

2 (5.3%)

15 (39.5%)

0 (0%)

0.003

 

 

 

 

SOFA score at initiation of therapy

4.8 ± 3.3 4.3 ± 2.6 0.49

Serum potassium at initiation, mg/dL

3.8 ± 0.5 3.8 ± 0.4 0.55

Serum phosphate at initiation, mg/dL

3.1 ± 1.0 3.1 ± 1.2 0.93

Serum magnesium at initiation, mg/dL

2.2 ± 0.6 2.3 ± 0.5 0.64 

Positive C. difficile toxin at initiation

2 (5.4%) 0 (0%) 0.34 

Neostigmine Characteristics

Total dose in first 24 hours, median (IQR), mg

Total dose received, median (IQR), mg

Duration of therapy

< 4 hours

4-8 hours

9-24 hours

25-48 hours

49-72 hours

>72 hours

Dose at bowel movement, mg/h

Received >1 dose

Time between doses, hours​

 

2.0 (2.0 to 2.6)

2.0 (2.0 to 4.0)

 

-

-

-

-

-

-

-

5 (13.5%)

10.5 ± 3.6

 

9.6 (6.3 to 9.6)

12.5 (8.2 to 19.4)

 

0 (0)

1 (2.6%)

19 (50%)

11 (28.9%)

6 (15.8%)

1 (2.6%)

0.4 ± 0.1

-

-

 

Results

Endpoint

Bolus (n= 37)

Infusion (n= 38)

p-value

Initial clinical response

23 (62.2%) 31 (81.6%) 0.06

Reduction in bowel diameter

15 (40.5%) 28 (73.7%)  0.0037 

Time to BM, median (IQR), hours

1.4 (0.975 to 11.1) 3.5 (2 to 11.43) 0.048 

Second neostigmine course after treatment

12 (32.4%) 10 (26.3%) 0.56 

Colonic decompression after treatment

25 (67.6%) 15 (39.5%) 0.015 

Surgical intervention after treatment

0 (0%) 2 (5.3%) 0.49 

ICU length of stay, median (IQR), days

14.3 (6.95 to 18.75) 14.5 (8.7 to 17.45) 0.79 

Hospital length of stay, median (IQR), days

25 (11 to 39.75) 18 (15 to 25.5) 0.46 

In-hospital mortality

4 (10.8%) 2 (5.3%) 0.43 

Bradycardia

5 (13.5%) 15 (39.5%) 0.011 

Required atropine

4 (10.8%) 2 (5.26%) 0.43 

Adverse Events

See Results

Study Author Conclusions

Initial clinical response was similar between groups; however, continuous infusion neostigmine was associated with greater bowel diameter reduction at 24 hours. Bolus administration resulted in less bradycardia; however, given the lack of difference in atropine use, the clinical significance is unknown. This study is the first to compare bolus versus continuous infusion neostigmine for ACPO. Further studies are needed to confirm the findings.

InpharmD Researcher Critique

The study was unable to assess the reduction in bowel diameter as a continuous variable due to inconsistent documentation. Despite analyzing data worth a decade long, potential time-related changes in ICU practice and provider prescribing patterns were unmeasured. Such unidentified confounding variables may have impacted the response. Most importantly, for the primary outcome of initial clinical response, the study was underpowered to appropriately detect a difference between the two strategies.



References:

Smedley LW, Foster DB, Barthol CA, et al. Safety and Efficacy of Intermittent Bolus and Continuous Infusion Neostigmine for Acute Colonic Pseudo-Obstruction. J Intensive Care Med 2018:885066618809010.